Sr. Manager or Associate Director, Program Management – Clinical, Medical & Regulatory

Cabaletta Bio; Kentucky; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Cabaletta Bio is seeking a Sr. Manager / Associate Director, Program Management - Clinical, Medical & Regulatory to lead strategic planning and execution of clinical programs across development, operations, biometrics, medical affairs, and regulatory functions.

This hybrid role requires 7+ years (Sr. Manager) or 8+ years (Associate Director) of PM experience in biotech, with strong cross-functional leadership, proficiency in Smartsheet, and a track record of on-time, on-budget milestones.

Qualifications

• 7+ years of program management experience in biotech or cell and gene therapy.
• Experience supporting regulatory filings and inspections (INDs/BLAs).
• Strong cross-functional leadership and strategic planning skills.
• Proficiency with Smartsheet and PM tools; MS Office experience.
• Excellent communication and vendor management abilities.

Responsibilities

• Align program planning with CMR portfolio PM and PDT strategy.
• Develop project scope, timelines, budgets, and resource plans.
• Lead cross-functional study teams and governance meetings with action-item tracking.
• Partner with Clinical Operations, Regulatory, Biometrics, Medical Affairs to maintain plans and dashboards.
• Identify, score, and communicate risks with maintained risk registers and mitigation plans.
• Manage CROs, vendors, and contracts; lead vendor governance meetings.
• Support preparation and submission of INDs and BLAs with cross-functional teams.
• Prepare and present updates to senior management and key stakeholders.
• Advance enterprise PMO practices by creating PM tools and templates.
• Serve as Smartsheet Super User for project-level plans and dashboards.
• Travel 10-15% as required; work across time zones.

Skills

Smartsheet

Cross-functional leadership

Program management

Regulatory filings

Vendor management

Education

Advanced degree in Life Sciences

Tools

Smartsheet

Job description

Position Title:

Sr. Manager / Associate Director, Program Management - Clinical, Medical & Regulatory

Location:

Hybrid/Philadelphia, PA

Reports to:

Sr. Director, Program Management

Department:

Program Management Office

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients' own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

We're proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®

About The Position

Reporting into the PMO through the Sr. Director, Program Management, the Sr. Manager / Associate Director, Program Management - Clinical, Medical & Regulatory (CMR) leads the strategic planning, execution, and delivery of clinical programs uniting Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions and deliverables. This role operates as an embedded, matrixed member of the CMR organization while remaining part of the enterprise PMO, with close collaboration across cross-functional teams throughout the organization. Final level will be determined commensurate with the candidate's experience and demonstrated scope of leadership.

The Sr. Manager / Associate Director ensures all clinical program activities are robustly planned, continuously maintained, and risk-managed with contingency scenarios, and that program plans supporting an autologous cell therapy product remain aligned with overall asset timelines, corporate objectives, and strategic initiatives.

The ideal candidate brings 7+ years of program management experience for Sr. Manager level or 8+ years for Associate Director level in clinical trial environments within biotech or cell and gene therapy, advanced strategic planning skills, strong cross-functional leadership, and high proficiency in SmartSheet.

Responsibilities

• Work with the CMR portfolio PM and lead Asset PM to align program planning and execution with corporate objectives and Product Development Team (PDT) strategy.
• Develop project scope, timelines, budgets, and resource plans across the clinical portfolio.
• Lead cross-functional study team and governance meetings, including agendas, decision logs, minutes, action-item tracking, collaboration, and team alignment.
• Partner with Clinical Operations, Clinical Development, Biometrics, Medical Affairs, and Regulatory leaders to develop and maintain project plans, timelines, and dashboards for multiple clinical programs aligned with department and corporate objectives.
• Identify, score, and communicate risks through maintained risk registers with proactive mitigation and contingency plans; ensure department timelines and risk trackers integrate with the corporate portfolio and integrated roadmaps.
• Manage CROs, vendors, and external partners by tracking performance and contracts, escalating and resolving issues, leading vendor governance meetings, and cultivating durable relationships focused on on-time, quality delivery.
• Support preparation and submission of regulatory filings, including INDs and BLAs, in partnership with Clinical, Regulatory Affairs, Technical Development, and Supply Chain.
• Prepare and present project updates to senior management and key stakeholders to support decision-making; partner with Finance and Legal to facilitate on-time, on-budget milestone delivery.
• Advance enterprise PMO best practices by creating and using PM tools and templates that support continuous improvement and scalable processes.
• Serve as Smartsheet Super User by building and publishing project and portfolio-level plans, dashboards, and reports, and training team members on Smartsheet functionality.
• Work across time zones as necessary; travel 10-15% may be required; other duties as assigned.

Required Qualifications

• Experience in pharmaceutical or biotechnology industries is required.
• 7+ years of program management experience is required for Sr. Manager level; 8+ years is required for Associate Director level. Technical operations experience and cell and gene therapy, CAR-T, or similar industry experience are preferred.
• Direct experience supporting regulatory Health Authority Inspections in a GxP-regulated environment is required.
• Proficiency in MS Office, including Outlook, PowerPoint, Excel, and Word, and familiarity with project management tools are required.
• Strong understanding of PM best practices, PMO operating models, and scalable processes in a growing corporate environment is required.
• Extensive Smartsheet experience, including creating, maintaining, and reporting timelines, Gantt charts, dashboards, and reports.
• Excellent external-facing presence and experience managing vendor relationships and contracts.
• Strong verbal and written communication skills.
• Outstanding attention to detail with the ability to manage multiple tasks and priorities.
• Ability to work both independently and collaboratively with cross-functional teams.
• Thrives in a dynamic, fast-paced, timeline-based environment.
• Strong customer service focus as part of PM culture.

Preferred Qualifications

• Advanced degree in Life Sciences is preferred.
• Certification in project management, such as PMP or CAPM, is preferred.
• Experience with both early- and late-stage clinical programs is an advantage.
• Cell and gene therapy, CAR-T, or similar industry experience is preferred.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.